FDA 510(k) clearance · back to tracker

TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet)

Carl Zeiss Meditec, AG cleared K261361 on 2026-10-15, decision: substantially equivalent

K-number

K261361

Sponsor

Carl Zeiss Meditec, AG

Device

TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet)

Class

Class U

Decision

Substantially Equivalent

Decision date

2026-10-15

Product code

LFL

Advisory committee

Unknown

Medical specialty

Unknown

Regulation number

Official FDA record

Open K261361on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.